AstraZeneca pneumonia treatment on FDA fast-track

Regulators in the USA have fast-tracked a new treatment developed by AstraZeneca’s MedImmune unit to prevent pneumonia.

Specifically, the US Food and Drug Administration has granted fast-track designation to the investigational monoclonal antibody MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa. The latter is a highly drug-resistant bacterial pathogen that causes serious disease in hospitalised patients, AstraZeneca noted.

MEDI3902, which is going into Phase I, is engineered to combine three distinct mechanisms of action for disarming and clearing P. aeruginosa and in pre-clinical trials was found to produce enhanced effects for both prevention and treatment in multiple animal models.

Steve Projan, head of R&D for infectious diseases and vaccines at MedImmune, said that getting fast-track designation recognises “the unique science behind this investigational mAb and the importance of accelerating development of new medicines that may help prevent serious bacterial infections…rather than solely relying on antibiotics to treat them”.

He went on to say that “at a time when antimicrobial resistance poses an imminent and urgent global public health threat, it’s more important than ever than ever to develop new therapies that both prevent and treat hospital acquired infections”. Dr Projan added that the designation “will streamline communications with the FDA throughout the development process on what is a very different approach to the bacterial resistance problem”.